RECRUITING

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial studies how well intensity modulated proton therapy (IMPT) or intensity modulated X-ray (radiation) therapy (IMRT) works after surgery in treating patients with head and neck cancer. IMPT is a type of radiation therapy that allows for the most accurate application of proton radiation to the tumor and has the potential to reduce treatment-related side effects. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of x-ray radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. IMPT may work as well as IMRT after surgery in treating patients with head and neck cancer.

Official Title

HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers

Quick Facts

Study Start:2022-02-16
Study Completion:2026-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05075980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Histological confirmation of a newly diagnosed non-human papillomavirus (HPV) associated malignant epithelial cancer in the head and/or neck. Diagnosis requires confirmation of p16 and/or HPV DNA negativity for oropharyngeal and unknown primary sites. p16 positivity in skin cancers is allowed
  3. * Primary lesion located in the nasal cavity, paranasal sinuses, oral cavity, oropharynx, larynx, hypopharynx, salivary glands, lymph nodes (unknown primary or metastasis from head and neck \[HN\]-skin primary) or skin cancer where lymph node radiation is recommended
  4. * NOTE: Patients with primary lesions in the larynx must have a T3 primary, bulky T2 primary (\> 6 cc), and/or at least 1 regional lymph node
  5. * Confirmation of American Joint Committee on Cancer (AJCC) 8th edition defined M0 established by positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI)
  6. * Eastern Cooperative Oncology Group (ECOG) performance status (0-1 prior to initial treatment)
  7. * Able to provide written informed consent
  8. * Able to complete questionnaires independently or with assistance
  9. * Willing to return to enrolling institution for follow up during the observation phase
  1. * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  2. * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  3. * NOTE: Patients known to be HIV positive, but without clinical evidence of immunocompromised state, are eligible for this trial
  4. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  5. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  6. * Other active malignancy =\< 2 years prior to registration
  7. * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix and prostate cancer with a Gleason score of 6 or less
  8. * NOTE: If there is a history or prior malignancy, they must not be receiving ongoing anticancer treatment
  9. * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  10. * Prior radiation therapy that would have a clinically significant overlap with the intended head/neck radiation
  11. * For Arms A and B only: Unable to receive proton therapy because of extensive metallic hardware in close proximity to treatment site, logistical circumstances, or any other reason
  12. * Any of the following diagnoses: HPV-associated squamous cell carcinoma, germ cell tumors, hematologic malignancies, neuroendocrine malignancies, adenoid cystic carcinoma, sarcomas of bone, benign tumors

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Scott C. Lester, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, 56001
United States
Mayo Clinic Radiation Therapy - Northfield
Northfield, Minnesota, 55057
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54701
United States
Mayo Clinic Health System - Franciscan Healthcare
La Crosse, Wisconsin, 54601
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Scott C. Lester, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-16
Study Completion Date2026-11-15

Study Record Updates

Study Start Date2022-02-16
Study Completion Date2026-11-15

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Carcinoma
  • Head and Neck Carcinoma of Unknown Primary
  • Hypopharyngeal Carcinoma
  • Laryngeal Carcinoma
  • Metastatic Malignant Neoplasm in the Lymph Nodes
  • Nasal Cavity Carcinoma
  • Oral Cavity Carcinoma
  • Oropharyngeal Carcinoma
  • Paranasal Sinus Carcinoma
  • Salivary Gland Carcinoma
  • Cutaneous Squamous Cell Carcinoma of the Head and Neck
  • Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck